Identity
- Trade Name
- FETALSCREEN™II FDA UDI
- Generic Name
- Foeto-maternal haemorrhage/Kleihauer test IVD, control FDA UDI
- Device Name
- FETALSCREEN™ is a Qualitative Screening Test for RhD (Rho) positive fetal red blood cells in the maternal circulation. FDA UDI
- Model / Reference
- Z488 FDA UDI
- Description
- FETALSCREEN™ is a Qualitative Screening Test for RhD (Rho) positive fetal red blood cells in the maternal circulation. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10758750006144 FDA UDI
- FDA Product Code
- MTI FDA UDI
- GMDN Term
- Foeto-maternal haemorrhage/Kleihauer test IVD, control FDA UDI
Classification
- Device Class
- N FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Foeto-maternal haemorrhage/Kleihauer test IVD, control
Fetalscreen™ii by Alba Bioscience Limited — Class N — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class N | Pending data |
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Manufacturer
- Manufacturer
- Alba Bioscience Limited
Sources (1)
- FDA UDI 906f7e41-dc9d-480b-a37f-3a2a8226c3ca 34 fields · synced Jun 1, 2026